Current through Register 1531, September 27, 2024
(A)
Notice of Violation. Whenever the Department finds
upon inspection, investigation of a complaint or through information in its
possession that an applicant or licensee is not in compliance with provisions
of M.G.L. c. 111, §§ 5N through 5Q or a regulation promulgated
thereunder, the Department shall notify the applicant or licensee of such
violation or deficiency. The notice shall include a statement of the violations
or deficiencies found, the provision of the law relied upon, and a reasonable
period of time for correction. A violation or deficiency may result in denial,
suspension, revocation or refusal to renew a license or certificate of
inspection; a modification or limitation of a license; a cease and desist
order; and/or the imposition of a civil penalty and/or criminal
sanctions.
(B)
Plan of
Correction.
(1) The applicant or
licensee shall within ten days of receipt of the notice, file with the
Department a written plan of correction. The plan shall clearly identify the
licensee, state the date, reference the violation or deficiency cited, state
specific corrective action(s) and timetable(s) and date(s) for completion for
each deficiency cited, and shall be signed by either the applicant or licensee
or his or her designee.
(2) The
Department may reinspect a facility in order to determine whether the
corrections have been made. If upon review of plan of correction and/or
reinspection the Department finds that the applicant or licensee is in
compliance with
105 CMR
127.000 and/or that the applicant or licensee has
submitted an acceptable plan of correction, the Department shall notify the
applicant or licensee of its findings of compliance and/or its acceptance or
modification of the plan of correction.
(3) If upon review of plan of correction
and/or reinspection the Department finds the plan of correction is
unacceptable, the Department may request that the applicant or licensee amend
and resubmit the plan of correction with five days of the date of notice or
such other time as the Department may specify for resubmission.
(4) If upon review of the plan of correction
and/or reinspection the Department determines that an applicant or licensee
remains noncompliant with applicable laws and regulations regarding licensure,
the Department may initiate enforcement procedures as set forth in 105 CMR
128.037(C).
(C)
Notice of Department's Intent to Issue an Order.
(1) Prior to the Department issuing an order
to modify, limit, deny, revoke or refuse to renew a license, and/or to require
a person to cease and desist any activity, and/or to impose civil penalties,
the applicant or licensee shall be notified in writing of the grounds for the
Department's action, the provision(s) of law relied upon, the amount of any
civil penalty, and his or her right to request an adjudicatory proceeding
and/or judicial review.
(2) If a
license is to be denied, modified, limited, revoked or refused renewal or if an
activity is to be ceased or a civil penalty imposed by the Department, then the
aggrieved applicant or licensee may request an adjudicatory hearing within 21
days of receipt of notification of the Department's Intent to Issue an Order.
Said request shall be filed in accordance with Standard Adjudicatory Rules of
Practice and Procedures,
801 CMR
1.00: Standard Adjudicatory Rules of Practice
and Procedures.
(D)
Administrative Hearings:
Procedure.
(1)
Suspension of a License or Immediate Cessation of
Activity.
(a) The Department
shall give the licensee written notice stating the reason(s) for the suspension
or immediate cessation of an activity and the provisions of law relied upon.
The suspension or order of immediate cessation of an activity shall take effect
immediately upon issuance of the notice.
(b) The Department shall provide for a
hearing pursuant to
801 CMR
1.00: Standard Adjudicatory Rules of Practice
and Procedures promptly after the issuance of an order of suspension
or order of immediate cessation of an activity.
(c) In cases of suspension of a license or
immediate cessation of an activity, the Hearing Officer shall determine whether
the Department has proved by a preponderance of the evidence that there
existed, immediately prior to or at the time of the suspension or cease and
desist order, a threat to public health, safety or the environment.
(d) In the event that the Department
determines that the violation of state law or of
105 CMR
127.000 which posed a threat is corrected prior to the
decision of the Hearing Officer, the Department may lift the suspension by
giving written notice to the mammography facility.
(2)
Denial, Modification,
Limitation, Revocation, or Refusal to Renew a License Based on Failure to File
Reports or Pay Fees or Maintain Insurance. No hearing shall be
afforded where denial, modification, limitation, revocation, suspension or
refusal to review is based solely upon failure of the licensee to file timely
reports, schedules or applications or to pay lawfully proscribed fees, or to
maintain insurance coverage as required by any law or regulation. M.G.L. c.
30A, § 13(3).
(3)
Denial, Modification, Limitation, Revocation or Refusal to Renew a
License; Orders to Cease an Activity; Civil Penalties.
(a) All adjudicatory proceedings shall be
conducted in accordance with M.G.L. c. 30A and
801 CMR
1.00: Standard Adjudicatory Rules of Practice
and Procedures.
(b) Except
for circumstances specified in 105 CMR 127.037(D)(2), if the Department
determines that a license should be denied, modified, limited, revoked, or
refused renewal, and/or that a mammography facility should cease an activity,
and/or that a civil penalty should be imposed, and if the Department notifies
the applicant or licensee of its intended action, upon receipt of a Notice of
Claim for an Adjudicatory Proceeding, the Department shall initiate a hearing
pursuant to
801 CMR
1.00: Standard Adjudicatory Rules of Practice
and Procedures.
(c) The
Hearing Officer shall determine whether the Department has proved by a
preponderance of the evidence that the license should be denied, modified,
limited, revoked or refused renewal; that an activity should be ceased; and/or
that a civil penalty be imposed based on relevant facts as they existed at or
prior to the time the Department initiated the hearing procedure.
(d) If the Hearing Officer finds any single
ground for denial, modification, limitation, revocation, suspension, or refusal
to renew a license; for a cessation of an activity; and/or for imposition of a
civil penalty, then the Hearing Officer shall render a recommended decision
affirming the issuance of the Department's Order.
(4)
Final Agency Decision and
Judicial Review.
(a) The
recommended decision of a Hearing Officer in any adjudicatory proceeding
conducted under
105 CMR
127.000 shall be reviewed by the Commissioner. The
Commissioner's decision upon this review shall constitute a final agency
decision in an adjudicatory proceeding subject to judicial review pursuant to
M.G.L. c. 30A, § 14.
(b) Any
applicant or licensee that fails to exercise its right to an adjudicatory
proceeding under
105 CMR
127.000 waives both its right to administrative review
by the Commissioner and its right to judicial review pursuant to M.G.L. c. 30A,
§ 14.
(E)
Civil Penalties.
(1)
If the Department determines, after a notice has been issued and an opportunity
for a hearing has been provided, that a mammography facility has not complied
with an order issued pursuant to M.G.L. c. 111, § 50 or with any provision
of M.G.L. c. 111, §§ 5N through 5Q or with any applicable rule,
regulation, license or registration adopted or issued thereunder, the
Department, in lieu of, or in addition to suspending, denying,
modifying, limiting, revoking, or refusing renewal of a license, may assess
civil penalties in an amount not exceeding $ 100,000 per violation. Such civil
penalty may be assessed whether or not the violation was willful.
(2)
Factors in Determining Amount
of Penalty. In determining the amount of the civil penalty, the
Department shall consider the following:
(a)
The willfulness of violation;
(b)
The actual and potential danger to the public health or the
environment;
(c) The actual or
potential cost of such danger to the public health or the
environment;
(d) The actual or
potential damage or injury to the public health or environment;
(e) The actual and potential cost of such
damage or injury;
(f) The actual or
potential cost to the Commonwealth of enforcing provisions of
105 CMR
127.000;
(g) Whether the person being assessed the
civil penalty did everything reasonable to prevent failure to comply from
occurring, to come into compliance promptly, and to remedy and mitigate
whatever harm might have been done as a result of the failure to
comply;
(h) Whether the person
being assessed the civil penalty has previously failed to comply with any order
issued pursuant to M.G.L. c. 111, §§ 5N through 5Q or any other rule
or regulation adopted hereunder;
(i) Whether imposition of a civil penalty is
likely to deter future noncompliance;
(j) The financial condition of the person
being assessed the civil penalty; and
(k) The public interest.
(3)
Civil Penalty for Operation
without a License. Operation of a mammography facility without a
license constitutes a violation of law punishable by a civil penalty of up to
$100,000. Each day during which a mammography facility operates without a
license shall constitute a separate offense.
(4)
Payment of the Civil
Penalty. If after hearing, or waiver thereof, the Department
imposes a civil penalty then the civil penalty shall be due and payable to the
Commonwealth of Massachusetts on the 30th day after final agency
action.
(5)
Non-exclusivity of Civil Penalties. By imposing a
civil penalty, the Department does not waive its right to invoke other
enforcement procedures, such as modification, limitation, suspension,
revocation or refusal to renew a license, registration or certificate of
inspection.
(F)
Criminal Enforcement. The Department may elect to
enforce any section of
105 CMR
127.000 or provision of M.G.L. c. 111, § 5P by
seeking to have criminal sanctions imposed. Any person who violates M.G.L. c.
111, § 5N or 50 or any rule, regulation, license, registration, or order
adopted or issued under M.G.L. c. 111, § 5N or 50 shall be fined not less
than $100,000 nor more than $200,000, or be imprisoned for a period of not more
than two years, or both. Any person who continues to violate the provisions of
the aforementioned laws after due notice by the Department shall be fined not
less than $1,000 nor more than $20,000 or be imprisoned for a period of not
more than 20 years, or both. After due notice has been issued by the
Department, each day of such violation shall constitute a separate
offense.
(G)
Judicial
Enforcement. The Department may apply directly to the Supreme
Judicial Court or Superior Court to enforce any provision of M.G.L. c. 111,
§§ 5N through 5Q and/or any rule or regulation, license,
registration, or order adopted and issued thereunder by the Department. When a
person is engaged in or about to engage in any act or practice which
constitutes or will constitute a violation of such provision, rule, regulation,
license, registration, or order, the Department may seek to restrain such act
or practice or the use or occupation of premises or parts thereof or such other
equitable relief as public health and safety requires.
(H)
Non-exclusivity of
Enforcement Procedures. None of the enforcement procedures
contained in
105 CMR
127.000 are mutually exclusive. Any enforcement
procedures may be invoked simultaneously if the situation so
requires.
